Spillover Effects of Water, Sanitation, and Hygiene Interventions on Child Health

Diarrhea Clinical Trial

Official title:

Spillover Effects of Water, Sanitation, and Hygiene Interventions on Child Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396407
• Other study ID #: 1R21HD076216-01A1
• Secondary ID: 1R21HD076216-01A
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: October 25, 2016
• Start date: January 2015
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure whether a combined water, sanitation, and hygiene intervention leads to improved health of children who did not receive the intervention themselves and who live within a close vicinity of intervention recipients.

Description:

Almost 90% of diarrhea cases and 15% of under-5 diarrhea deaths worldwide could be prevented through improved water, sanitation, and hygiene. Sanitation interventions are also important for the prevention of soil-transmitted helminths, which infect 21 million children under five each year. Infection with soil-transmitted helminths and repeated episodes of diarrhea early in life can compromise physical and cognitive growth and development, resulting in poorer school performance later in life. Thus, water, sanitation, and hygiene (WASH) interventions are important not only for reducing child mortality, but also for preventing cycles of poverty and poor health.

It is possible that WASH interventions affect not only those who receive them but also those who are geographically proximate or connected socially to those receiving the intervention. Indeed, there is a large infectious disease modeling literature based on this premise. Investigators define intervention effects on non-recipients "spillovers", and they are often referred to as "herd effects" or "indirect effects". Most studies that have empirically measured spillovers of child health interventions with an experimental design have focused on vaccines and deworming, and no studies have measured spillovers from WASH interventions. The development and application of methodology for measuring spillovers of community interventions empirically would make a valuable contribution to fields including epidemiology, economics, political science, and social welfare, all of which are concerned with measuring the impact of programs and interventions which may spill over. The presence and magnitude of positive spillovers are important; if spillovers are present and are in the same direction as treatment effects but are not accounted for when estimating treatment effects, estimates will be biased towards the null. As a result, both the efficacy and cost effectiveness of the intervention will be underestimated.

In this study, investigators will measure spillovers of water, sanitation, and hygiene interventions in an existing, large, rigorously designed trial: the WASH Benefits trial (https://clinicaltrials.gov/ct2/show/NCT01590095). Funded by the Bill & Melinda Gates Foundation, this trial aims to measure the individual and combined effects of water, sanitation, and hygiene interventions on child health and development. It is a cluster-randomized, controlled trial with six treatment arms and a double-sized control arm carried out in rural Bangladesh. This add-on study is funded by the National Institute for Child Health and Human Development (1R21HD076216-01A1). Investigators hypothesize that children who live in close proximity to compounds that receive a combined sanitation, handwashing, and water treatment intervention--compared to children who live in close proximity to control compounds (no intervention)--will have: 1) lower prevalence of diarrhea, 2) lower prevalence and intensity of infection of soil transmitted helminths, and 3) lower prevalence of respiratory illness.

Investigators will collect additional data from the existing combined intervention (sanitation+handwashing+water) and control arms of the WASH Benefits trial. For each WASH Benefits household, investigators will locate the nearest household with children 0-59 months of age that are not enrolled in WASH Benefits and collect data in that household. Our primary outcomes are soil transmitted helminth infection among children 0-59 months, caregiver-reported 7-day diarrhea, and respiratory illness among children 0-59 months (the same age as the WASH Benefits cohort). Our findings will document either the presence or absence of spillovers of the combined sanitation+handwashing+water intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1789
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 60 Months

Eligibility

Inclusion Criteria:

• Children not enrolled in WASH Benefits who live in a compound within 120 steps (2 minutes walking time) of a compound enrolled in WASH Benefits (combined WSH or control arms) and are 0-60 months 24 months after intervention

Exclusion Criteria:

• Children enrolled in WASH Benefits

• Children who live in compounds (baris) that share a courtyard with a compound enrolled in the WASH Benefits study

• Children who live in compounds (baris) that share a latrine or handwashing station with a compound enrolled in the WASH Benefits study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Helminthiasis
• Respiratory Infection
• Respiratory Tract Infections

Intervention

Behavioral:
• Combined water, sanitation, and hygiene
Water: Free chlorine tablets (Aquatabs; NaDCC) and safe storage vessel to treat and store drinking water. Sanitation: Free child potties, sani-scoop hoes to remove feces from household, and latrine upgrades to a dual pit latrine for all households in study compounds. Handwashing: Handwashing stations including soapy water bottles and detergent soap. Local promoters visit study compounds at least monthly to deliver behavior change messages that focus on (1) treating drinking water for children < 36 months of age, (2) use of latrines for defecation and the removal of human and animal feces from the compound, and (3) handwashing with soap at critical times around food preparation, defecation, and contact with feces.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Berkeley	Bill and Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), International Centre for Diarrhoeal Disease Research, Bangladesh, Stanford University

Country where clinical trial is conducted

Bangladesh, 

References & Publications (7)

Arnold BF, Null C, Luby SP, Unicomb L, Stewart CP, Dewey KG, Ahmed T, Ashraf S, Christensen G, Clasen T, Dentz HN, Fernald LC, Haque R, Hubbard AE, Kariger P, Leontsini E, Lin A, Njenga SM, Pickering AJ, Ram PK, Tofail F, Winch PJ, Colford JM Jr. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale. BMJ Open. 2013 Aug 30;3(8):e003476. doi: 10.1136/bmjopen-2013-003476. — View Citation

Dreibelbis R, Winch PJ, Leontsini E, Hulland KR, Ram PK, Unicomb L, Luby SP. The Integrated Behavioural Model for Water, Sanitation, and Hygiene: a systematic review of behavioural models and a framework for designing and evaluating behaviour change interventions in infrastructure-restricted settings. BMC Public Health. 2013 Oct 26;13:1015. doi: 10.1186/1471-2458-13-1015. Review. — View Citation

Ercumen A, Naser AM, Unicomb L, Arnold BF, Colford JM Jr, Luby SP. Effects of source- versus household contamination of tubewell water on child diarrhea in rural Bangladesh: a randomized controlled trial. PLoS One. 2015 Mar 27;10(3):e0121907. doi: 10.1371/journal.pone.0121907. eCollection 2015. — View Citation

Hulland KR, Leontsini E, Dreibelbis R, Unicomb L, Afroz A, Dutta NC, Nizame FA, Luby SP, Ram PK, Winch PJ. Designing a handwashing station for infrastructure-restricted communities in Bangladesh using the integrated behavioural model for water, sanitation and hygiene interventions (IBM-WASH). BMC Public Health. 2013 Sep 23;13:877. doi: 10.1186/1471-2458-13-877. — View Citation

Lin A, Arnold BF, Afreen S, Goto R, Huda TM, Haque R, Raqib R, Unicomb L, Ahmed T, Colford JM Jr, Luby SP. Household environmental conditions are associated with enteropathy and impaired growth in rural Bangladesh. Am J Trop Med Hyg. 2013 Jul;89(1):130-7. doi: 10.4269/ajtmh.12-0629. Epub 2013 Apr 29. — View Citation

Sultana R, Mondal UK, Rimi NA, Unicomb L, Winch PJ, Nahar N, Luby SP. An improved tool for household faeces management in rural Bangladeshi communities. Trop Med Int Health. 2013 Jul;18(7):854-60. doi: 10.1111/tmi.12103. Epub 2013 Apr 5. — View Citation

Vujcic J, Ram PK, Hussain F, Unicomb L, Gope PS, Abedin J, Mahmud ZH, Islam MS, Luby SP. Toys and toilets: cross-sectional study using children's toys to evaluate environmental faecal contamination in rural Bangladeshi households with different sanitation facilities and practices. Trop Med Int Health. 2014 May;19(5):528-36. doi: 10.1111/tmi.12292. Epub 2014 Mar 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of soil-transmitted helminths (Ascaris, hookworm, Trichuris)	Children's stool will be collected. Kato-Katz will be used to detect Ascaris, hookworm, Trichuris ova in stool. Stool samples with any ova will be considered positive.	Measured approximately 24 months after intervention	No
Primary	Intensity of soil-transmitted helminth infections (Ascaris, hookworm, Trichuris)	Children's stool will be collected. Kato-Katz will be used to detect Ascaris, hookworm, Trichuris ova in stool. Intensity will be measured using WHO cutoffs based on the number of eggs per gram of stool (>=5,000 eggs/gram for Ascaris, >=1,000 eggs/gram for hookworm, and >=2,000 eggs/gram for Trichuris).	Measured approximately 24 months after intervention	No
Secondary	Diarrhea prevalence	Diarrhea is defined as 3+ loose or watery stools in 24 hours or 1+ stools with blood in 24 hours. Diarrhea will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 24 months after intervention.	Measured approximately 24 months after intervention	No
Secondary	Respiratory illness prevalence	Respiratory illness is defined as a persistent cough or difficulty breathing in the 7 days before the interview. Respiratory illness will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 24 months after intervention.	Measured approximately 24 months after intervention	No

External Links

•   Description of the design and rationale for WASH Benefits (open access article)
•   WASH Benefits Bangladesh ClinicalTrials.gov Registration